Nasopharyngeal Carcinoma Clinical Trials

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Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial

Who is this study for? Patients with locoregionally advanced nasopharyngeal carcinoma with malnutrition
Status: Recruiting
Location: See location...
Intervention Type: Other, Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);

• All genders,range from 18~65 years old;

• Karnofsky performance status(KPS) ≥ 80;

• Clinical stage III\

⁃ IVa(AJCC/UICC 8th);

• Without significant digestive system disease,nutritional and metabolic diseases or endocrine disease

• Without significant cardiac,respiratory,kidney or liver disease;

• Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy);

• White blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L

• Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN);

• Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);

• No contraindications to chemotherapy or radiotherapy;

• Inform consent form;

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Jingjing Miao, MD
miaojingjing90@163.com
86-13631355201
Time Frame
Start Date: 2021-08-16
Estimated Completion Date: 2029-12
Participants
Target number of participants: 266
Treatments
Experimental: Standard nutrition therapy
Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.
Active_comparator: Conventional nutrition therapy
Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.
Related Therapeutic Areas
Sponsors
Collaborators: Jiangxi Provincial Cancer Hospital, The First Affiliated Hospital of Xiamen University, Cancer Hospital of Guizhou Province, Fudan University, Zhejiang Cancer Hospital, Xijing Hospital, Zhongnan Hospital, Fujian Cancer Hospital, Xiangya Hospital of Central South University
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov